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A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children

BioNTech SE · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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covid-19sars-cov-2-infection
The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children. Sub study A of this clinical trial will test up to four different dose levels of the vaccine in infants who are under 6 months of age and have not previously received a coronavirus vaccination. This will be a 3- dose primary series of the study vaccine with each dose separated by 8 weeks.
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